Medical Devices Risk Management

Randy Keen

B I OCOMPATIBILITY TOXICOLOGY

MEDICAL DEVICES

Details

Henderson, NV

United States

**********@*****.***

Skills

Biocompatibility Toxicology of

Medical Devices

• EU MDR 2017/745 Regulation

on Medical Devices

ISO 10993-1:2018 - Biological

evaluation and testing of medical

devices within a risk management

process

ISO 10993-18:2020 – Chemical

characterization of medical

device materials within a risk

management process

Materials Science and

Biocompatible Materials

Profile

Randy E. Keen · Medical Devices and Pharma experience · · Director of Discovery Research at Johnson & Johnson Pharmaceutical Research (JJPRD). Postdoc Chemistry, Ph.D. Biomedical Physics, M.A. Molecular Biology · · · Executive on J&J Discovery Research Portfolio Review Committee, making Go/No Go decisions on genetically driven small molecule and biologic drug candidates (IND). Business development of technology companies funded by Equity Capital / Venture Capital firms, including Sequoia Capital and Medical Science Partners (MSP, a Harvard / MIT Venture Fund), and Fjord Ventures. Possess 29 years of Life Science experience in pharma, medical devices, and materials science. Includes work in: Medical device and pharma technology development, External Innovation Officer, synthetic biology, biomarkers, imaging of in-vivo human brain and myocardium using Positron Emission Tomography (PET), Determination of Cerebral Protein Synthesis Rates and Neurological Disease in Humans Using PET Imaging at UCLA School of Medicine, semiconductor chips for DNA synthesis and gene synthesis, chemical engineering of medical devices (implantable and non-implantable), hydrogels, nanomaterials for medical imaging and diagnostics, biocompatible materials, chemical compatibility evaluations, molecular diagnostics on semiconductor chips, continuous glucose monitors (CGM), medical device manufacturing in GLP and GMP facilities, ISO 10993-1 Biocompatibility-Toxicology risk assessments of medical devices. Employment History

Principal Consultant, RK Consulting, Henderson

JANUARY 2 0 1 8 — PRESENT

Consulting firm – Early genetically driven target discovery of drugs. Example: Chemical synthesis of HIV and library of resistant variant genomes for development of drug PREZISTA ® (darunavir) a prescription HIV-1 (Human Immunodeficiency Virus type-1) medicine (at Johnson & Johnson). Engineering implantable/non-implantable medical devices. Manufacturing medical devices in GLP/GMP facilities. Medical device quality engineering and quality assurance (QA). Biocompatibility / Toxicology Risk Assessment Subject Matter Expert (SME), ISO 10993-1:2018 Biocompatibility / Toxicology, EU MDR 2017/745 Regulation on Medical Devices, EU MDR remediation, FDA regulations (21 CFR 820), CAPA, Gap Analysis, and FDA submissions. ISO 13485 Quality Assurance (QA), Regulatory Affairs (RA), Chemical Engineering, Materials Science, biocompatible materials, and manufacturing implantable and non-implantable medical devices. Positron emission tomography (PET) radiochemistry of molecular probes for Neurology and Cardiology disease. Development of MRI contrast agents – paramagnetic iron oxide nanoparticles

(PIOX). Hydrogel chemistry, lipid nanoparticles for diabetic retinopathy therapy, and polymer chemistry.

Engineer and Biocompatibility / Toxicology Subject Matter Expert (SME), Olympus Surgical Technologies America

AUGUST 2 0 2 2 — S E P T EMBER 2 0 2 3

• Supported Olympus Surgical as an Engineer and Biocompatibility / Toxicology Subject Matter Expert (SME) with expertise in Chemistry and biocompatible materials/polymers

• Performed EU MDR Remediation for implantable and non-implantable devices

• Selected and leveraged worst-case test articles to cover large, complex product families

• Determined biocompatibility and chemical characterization tests required for EU MDR remediation

• Updated legacy documentation and performed gap analysis to support EU MDR Remediation

• Agile / Oracle - Product Lifecycle Management (PLM) Database Software Oracle

• EU MDR 2017/745 Regulation on Medical Devices

• ISO 10993-1:2018 - Biological evaluation of medical devices, Parts 1-23

• ISO 13485 Medical Devices – Quality Management Systems (QMS)

• ISO 14971 Medical Devices - Application of risk management to medical devices

• 21 CFR 820 FDA Medical Devices – Quality System Regulation

• Wrote Olympus Surgical biological safety plans, test reports, risk assessments Biological Risk Assessments Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) EU MDR 2017 745 Clause 10.4 Compliance o o o o Master File Toxicological Information Search Documents

• ISO-10993-17 – Allowable Limits of Leachable Substances

• ISO-10993-18 – Chemical Characterization of materials

• Evaluated Materials for changes / new product development

• Determined Toxicological Impact

Engineer and Biocompatibility / Toxicology Subject Matter Expert (SME), Zimmer Biomet

AUGUST 2 0 2 1 — J UNE 2 0 2 2

• Supported Zimmer Biomet as an Engineer and Biocompatibility / Toxicology Subject Matter Expert (SME) with expertise in Chemical engineering and biocompatible materials/polymers

• Performed EU MDR Remediation and addressed CAPAs for implantable devices

• Selected and leveraged worst-case test articles to cover large complex product families

• Determined biocompatibility and chemical characterization tests required for EU MDR remediation

• Updated legacy documentation and performed Gap assessments to support EU MDR Remediation

• Wrote Zimmer Biomet biological safety plans, test reports, memos, risk assessments o Biological Risk Assessments o Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER)

• EU MDR 2017/745 Regulation on Medical Devices

• ISO 10993-1:2018 - Biological evaluation of medical devices, Parts 1-23

• ISO 13485 Medical Devices – Quality Management Systems (QMS)

• ISO 14971 Medical Devices - Application of risk management to medical devices

• 21 CFR 820 FDA Medical Devices – Quality System Regulation

• ISO-10993-17 – Allowable Limits of Leachable Substances

• ISO-10993-18 – Chemical Characterization of materials

• Evaluated candidate manufacturing process flows to minimize risk for final finished goods

• Evaluated Materials for changes / new product development

• Determined toxicological impact

Chief Scientific Officer (CSO) and Founder, Crescendo Bio Corporation, Laguna Hills

JANUARY 2 0 0 7 — JANUARY 2 0 1 8

Chemical synthesis on a semiconductor chip company. Crescendo Bio is focused on developing the chemical synthesis of DNA / Genes / Genomes on a semiconductor chip. The low-cost synthesis-on-a-chip technology will serve as the basis for a scalable, high-capacity genome foundry. Crescendo Bio is a semiconductor chip and synthetic biology company that will address the unmet needs of the Global Biotech, Pharma, Academic, and Defense research sectors.

Principal Chemical Engineer, Head of Sensors, Metronom Health, Laguna Hills

JANUARY 2 0 1 6 — JANUARY 2 0 1 8

Engineered new types of sensors for a continuous glucose monitor (CGM). This is an opto-enzymatic sensor that continuously measures human glucose levels and transmits the information to an iWatch or iPhone. Responsibilities:

• Set up and managed Chemical / Biochemical Engineering Laboratories from scratch. o Set up labs at non-GMP R&D site in Laguna Hills, California o Set up GMP / Cleanroom facilities in California and Arizona for manufacture of enzyme hydrogels, protein hydrogels, and O2 sensing polymer chemistries for first in human (FIH).

• Developed and optimized enzyme hydrogels for detection of glucose levels in vitro and in vivo. o Characterized enzymology, enzyme activity, physical properties of enzyme hydrogels, and enzyme stability. o Developed chemical and biochemical assays to measure build-out of enzyme hydrogel structures.

• Developed and optimized oxygen sensing polymers

• Developed and optimized oxygen transport (e.g., hemoglobin) hydrogels

• Developed and optimized fill and cure of multiple layers of hydrogel polymer structures in functional biosensor device.

• Screening of enzyme, protein, and O2 sensing molecules and formulations for desired functional properties.

• In charge of ISO 10993-1 Biocompatibility, Toxicology, and Sterilization of medical device products with NAMSA, Nelson Laboratories, Sterigenics, and other vendors.

Principal Consultant, Kato Pharmaceuticals, Laguna Hills JANUARY 2 0 1 7 — JANUARY 2 0 1 8

Kato Pharmaceuticals is a venture capital startup developing its first product for the treatment of diabetic retinopathy. The drug is a small molecule-containing liposome formulation that is administered directly into the vitreous humour of the eye. The liposome formulation is moving into GMP manufacture for first in human (FIH) trials. Account Manager Western USA, Advance Technology Division, AIC – American International Chemical, Framingham

JANUARY 2 0 1 6 — DECEMBER 2 0 1 6

AIC - American International Chemical, Advanced Technology Division is an ISO 9001-NACD/RDP supplier/. I was responsible for sales and customer service for GMP, non-GMP, ACS, and USP grade raw materials, chemicals, organic solvents, and biotech reagents to the Diagnostics, Pharma and Biotech companies in the Western United States.

Principal Consultant, Fjord Ventures, LLC, Laguna Hills JANUARY 2 0 0 7 — JANUARY 2 0 1 6

Fjord Ventures provides a highly capital efficient shared infrastructure to Portfolio companies and offers a dedicated funding source through Fjord Capital Partners.- Fjord Ventures is focused on Medical Devices and Diagnostics, Biotechnology, Pharmaceuticals and Life Science companies. I am the Founder, President and CSO of Crescendo Bio Corp. which is one of the Fjord Ventures Portfolio companies. Principal Consultant, Codon Devices, Inc., Cambridge JANUARY 2 0 0 6 — JANUARY 2 0 0 7

Advised Codon Devices on business plan development, marketing, sales, and value proposition strategies for the commercialization of products targeted to the Pharma, Biopharma, and Biofuels sectors.

Director – Pharmaceutical Discovery Research, Johnson & Johnson, San Diego

JANUARY 2 0 0 4 — JANUARY 2 0 0 7

• Early genetically driven target discovery and commercialization of new biologics and small-molecule drugs based on human and viral genomics. Architect and Head of J&J Center of Excellence (CoE) for DNA, Gene, and Genome Synthesis and DNA Sequencing located in La Jolla, CA. This is biological READ and WRITE technology of genes and DNA. Responsibilities: Served on Johnson & Johnson Executive Pharmaceutical Discovery Research Portfolio Review Committee providing Go/No Go decisions on advancement of biopharmaceuticals and small drug candidates. Synthesis of Library of HIV genome variants and other libraries of virus genomes Principal Architect of J&J Synthetic Gene / Synthetic Biology Center of Excellence (CoE). Leveraged gene and genome synthesis technology platform across J&J Global Pharma Group companies resulting in the commercialization of the best-in-class HIV drug PREZISTA®

(darunavir) Designed new state-of-the-art DNA Chemistry Laboratory and Genome Synthesis Pilot Plant to support unmet needs of Johnson and Johnson Global Pharma Groups. Presented Johnson & Johnson/Egea Protein Optimization technology to Wall Street Analysts – J&J Global Pharma Day, May 2005, New York.

Director of Research for DNA Chemistry and Gene Synthesis, Egea Biosciences, Inc., San Diego

JANUARY 2 0 0 1 — JANUARY 2 0 0 4

Responsibilities:

• Managing Director of Discovery Research and Technology Groups

• Managed DNA Sequencing group

• Managed and developed world-class DNA, Gene, and Genome Synthesis Technology

• Developed Best-in Class Gene and Genome Synthesis Platform which led to acquisition of Egea by Johnson & Johnson in May 2004. Chief Technology Officer (CTO) and Founder, KeenSense, Inc., San Diego JANUARY 1 9 9 6 — JANUARY 2 0 1 2

Medical Device company - Molecular Wire Injection Sensors for bioanalyte detection. Company IP includes US and International patents describing “Molecular Wire Injection Sensors”. Molecular wire injection sensors are composed of proteins electrically connected to semiconductor surfaces with molecular wires and conducting polymers. Semiconductor biochip sensors are used for continuous glucose monitoring (CGM), “lab-on-a-chip” matrix applications, and other continuous biosensor monitoring applications.

Head of Contract Research Organization (CRO), Keen Ångstrom Materials Research [KÅMR], San Diego

JANUARY 1 9 9 6 — JANUARY 2 0 0 1

• UCLA School of Medicine, DOE Laboratory of Structural Biology and Molecular Medicine (LSBMM), Los Angeles, CA o Research Contract granted to KÅMR to develop and characterize positron-labeled acyclovir derivatives that bind to TSK protein variants (reporter gene) for In-Vivo Imaging of Human Gene Expression with Positron Emission Tomography (PET). o Chemical / Enzymatic Synthesis of 8-Fluoroadenosine. Controversy over its true synthesis for over 20 years

(published in T et r ahed r o n L ette r s, 1998). Chief Operating Officer, Keen Ångstrom Materials Research [KÅMR], San Diego

JANUARY 1 9 9 4 — JANUARY 1 9 9 9

Consulting firm focused on materials science, nanoelectronics, nucleic acid chemistry, molecular biology, diagnostics, biochemistry, and semiconductors. Selected clients / projects noted below:

• Sequoia Capital, Menlo Park, CA o Technology and business evaluations for potential investments in start-up companies.

• LXN Corporatiion, San Diego, CA o Consultant to evaluate new continuous glucose sensor technologies.

• Medical Science Partners, L.P. (MSP), Brookline, MA o Technology and business evaluations for potential investments in start-up companies.

• City of Hope, Department of Diabetes, Endocrinology & Metabolism, Duarte, CA o Identification, characterization and purification of antigenic determinants for Type 1 diabetes mellitus (IDDM). Used as a predictive biomarker of future IDDM.

• NutraLert, Inc., Santa Monica, CA o Founding Director of Research and consultant for business development of new solid- state sensor technologies.- Sensors were developed for real-time detection of caffeine, sugars, lipids and other compounds found in food.

Principal Consultant, Sequoia Capital, Menlo Park

JANUARY 1 9 9 4 — JANUARY 1 9 9 6

Performed due diligence of Medical Device, Biotech, and Pharma companies. Evaluated technology, business development, and potential investments in start-ups and established companies. Sequoia Capital has partnered with founders of companies that now have an aggregate public market value of over $5.3 trillion since 1972, at every stage of growth.

Principal Consultant, Medical Science Partners, LP, Brookline JANUARY 1 9 9 4 — JANUARY 1 9 9 7

Performed due diligence of Medical Device, Biotech, and Pharma companies. Evaluated technology, business development, and potential investments in start-ups and established companies. Medical Science Partners (MSP) is a Harvard / MIT Venture Fund investing in Pharma, Biotech, and Medical Device companies. Education

Postdoc, UCLA Department of Chemistry and Biochemistry Ph.D., UCLA School of Medicine, United States Department of Energy

(DOE) Laboratory of Structural Biology and Molecular Medicine (LSBMM) M.A., UCLA Molecular Biology Institute

B.A., University of California, San Diego (UCSD)

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